A Study of Thymic Humoral Factor (THF Gamma 2) in HIV-Infected Patients

NCT ID: NCT00002435

Last Updated: 2005-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL

Brief Summary

To investigate the safety of thymic humoral factor (THF gamma 2), its effect on HIV load based on at least a 75 percent decrease in HIV quantitative PCR RNA copies/ml, and its persistence when administered in combination with an antiretroviral nucleoside derivative (zidovudine; AZT). To assess the effects of THF gamma 2 on T-cells, quality of life, and progression of disease.

Detailed Description

All patients receive 12 weeks of AZT before being randomized to self-administer one of two doses of THF gamma 2 or placebo for 15 consecutive days and then twice weekly for an additional 50 weeks.

Conditions

HIV Infections

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Thymic Humoral Factor

Intervention Type: DRUG

Zidovudine

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

Concurrent Medication:

Allowed:

• AZT or another antiretroviral agent (marketed or investigational under a Treatment IND).
• Primary prophylaxis for Pneumocystis carinii pneumonia (PCP), toxoplasmosis, and Mycobacterium avium-intracellulare (MAI) if patient's CD4 count decreases to < 200 cells/mm3.
• Other marketed drugs as required.

Patients must have:

• HIV seropositivity and be either asymptomatic or have persistent generalized lymphadenopathy (PGL).
• No history of symptoms in Category B or C of 1993 Case Definition, other than oral candidiasis following previous broad-spectrum antibiotic therapy.
• Mean CD4 of 200-500 cells/mm3.
• HIV-1 positive PCR RNA.
• Ability to self-administer study drug by IM injection.
• Ability to tolerate AZT at 600 mg daily during first 8 weeks of run-in period (if AZT naive) OR tolerated AZT at >= 500 mg daily for at least 3 months but no more than 12 months prior to randomization.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

• Malignancy.
• Hematuria.
• Proteinuria > 1+.

Concurrent Medication:

Excluded:

• Non-antiretroviral agents with known or suspected activity against HIV.
• Investigational new drugs that are not antiretroviral agents distributed under a Treatment IND.

Patients with the following prior conditions are excluded:

Myositis within the past 6 months.

Prior Medication:

Excluded:

• Experimental therapy, including interleukin-2, interferon, erythropoietin, or filgrastim nucleoside within 6 weeks prior to study entry.
• Prior antiretroviral therapy (AZT-naive patients only).

Prior Treatment:

Excluded within 6 weeks prior to study entry:

• Blood transfusion or blood products. Active alcoholism, drug abuse, or a mental or psychiatric problem sufficient to prevent adequate compliance with study.

• Minimum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pharmacia

INDUSTRY

Sponsor Role: lead

Locations

UCI

Irvine, California, United States

Southwest Community Based AIDS Treatment Group - COMBAT

Los Angeles, California, United States

San Francisco Veterans Administration Med Ctr

San Francisco, California, United States

Gottlieb Med Group

Sherman Oaks, California, United States

Mem Hosp Hollywood

Hollywood, Florida, United States

Goodgame Med Group

Maitland, Florida, United States

Chelsea Village Med Ctr

New York, New York, United States

Portland Veterans Adm Med Ctr / Rsch & Education Grp

Portland, Oregon, United States

Dr Alfred F Burnside Jr

Columbia, South Carolina, United States

Infectious Disease Physicians Inc

Annandale, Virginia, United States

Countries

United States

Other Identifiers

CS 112010-999

Identifier Type: -

Identifier Source: secondary_id

136A

Identifier Type: -

Identifier Source: org_study_id